Effects of Booster Sessions on Depression Vulnerability Following Cognitive Control Training
- Conditions
- Major Depression in Remission
- Interventions
- Behavioral: Cognitive Control Training (CCT)Behavioral: Cognitive Control Training (CCT) + Booster Sessions
- Registration Number
- NCT05557760
- Lead Sponsor
- University Ghent
- Brief Summary
The current study aims to examine the impact of booster sessions of cognitive control training (CCT) on indicators of depression vulnerability. Remitted depressed individuals (RMD) will be randomized over two groups, each receiving 10 sessions of the adaptive Paced Auditory Serial Addition Task, a well-established CCT procedure (Koster et al., 2017; Siegle et al., 2007). During and following completion of the training procedure, functioning will be monitored on a weekly basis over a period of 15 weeks. During this period, one group will be offered booster sessions based on early warning signs for possible recurrence of depression, whilst the other group will not receive booster sessions.
- Detailed Description
Cognitive impairments are closely associated with depression and recent studies have found that these cognitive problems can persist following remission of depression. Internet-delivered cognitive control training (CCT), and the adaptive Paced Auditory Serial Addition Task (aPASAT) in particular, has shown to be an effective preventative intervention for remitted depressed individuals (RMD), where beneficial effects have been found for rumination, depressive symptomatology (Hoorelbeke \& Koster, 2017), and risk for recurrence of depression (Hoorelbeke et al., 2021). At the same time, prior studies suggest significant heterogeneity in response to CCT, where RMD individuals can show strong fluctuations in functioning in the months following completion of aPASAT training. In line with this, recent findings suggest that, for individuals with high-risk profiles, initial training gains may diminish over time, resulting in recurrence of internalizing symptomatology (Hoorelbeke et al., 2022). As such, there may be merit in the use of CCT booster sessions.
Currently, it is unclear whether offering additional CCT sessions when RMD individuals are reporting increased symptomatology (i.e., adding booster sessions based on early warning signs for possible recurrence of depression) can increase the long-term effectiveness of CCT. In this study, two groups of RMD individuals will perform 10 CCT sessions, after which one group will be offered booster sessions (contingent on indicators of functioning). For this purpose, we will rely on 15 weekly mobile assessments, using the PHQ-9 questionnaire. In addition, functioning will be assessed using a more extensive assessment battery at baseline, post-training (2 weeks after baseline) and follow-up (15 weeks after baseline).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 138
- History of ≥ 1 depressive episode(s)
- Currently in remission (≥ 3 months)
- Access to a computer with an internet connection
- Access to a smartphone
- Ongoing depressive episode
- Psychotic disorder (current and/or previous)
- Neurological impairments (current and/or previous)
- Excessive substance abuse (current and/or previous)
- Use of antidepressant medication is allowed if kept at a constant level
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Control Training Group Cognitive Control Training (CCT) - Cognitive Control Training + Booster Sessions Group Cognitive Control Training (CCT) + Booster Sessions -
- Primary Outcome Measures
Name Time Method Change in Patient Health Questionnaire (PHQ-9) weekly assessments from baseline until follow-up (15 weeks after baseline) Self-report questionnaire measuring depression symptomatology, with higher scores indicating more severe depression symptoms.
- Secondary Outcome Measures
Name Time Method Change in non-adaptive PASAT performance baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline) A non-adaptive computerized version of the Paced Auditory Serial- Addition Task (PASAT) was used as a measure of participants' working memory abilities. Higher accuracy scores suggest greater cognitive control resources.
Change in Beck Depression Inventory (BDI-II-NL) baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline) Self-report questionnaire measuring depression symptomatology, with higher scores indicating more severe depression symptoms.
Change in Adult Temperament Questionnaire (ATQ), Effortful Control subscale baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline) Measured by the subscale Effortful Control (EC) from the Adult Temperament Questionnaire (ATQ).
Change in Remission from Depression Questionnaire (RDQ-NL) baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline) The Remission from Depression Questionnaire has 41 items, which assess domains such as positive mental health, life satisfaction, and sense of well-being. The items are scored 0 (not at all or rarely true), 1 (sometimes true) or 2 (often or almost always true).
Change in Short Form Health Survey (SF-36) baseline, follow-up (15 weeks after baseline) The 11-item SF-36 measures attitudes on general health.
Change in Perseverative Thinking Questionnaire (PTQ-NL) baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline) Change from baseline in repetitive negative thinking. The PTQ-NL consist of 15 items which are rated from 0 (never) to 4 (almost always). Lower scores indicate lower levels of repetitive negative thinking.
Change in Cognitive Emotion Regulation Questionnaire (CERQ) baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline) Self-report measure for emotion regulation: a 36-item questionnaire, consisting of adaptive and maladaptive emotion regulation strategies. Each item is rated on a 1 to 5 scale (1 = almost never and 5 = almost always).
Change in Burnout Assessment Tool (BAT) baseline, post training (2 weeks after baseline), follow-up (15 weeks after baseline) The Burnout Assessment Tool (BAT) is used to assess burn-out risk. The score ranges from 1 to 5, with higher scores indicating a higher risk of burn-out
Change in Work Productivity and Activity Impairment Questionnaire (WPAI) baseline, follow-up (15 weeks after baseline) The 6-item WPAI measures the effect of health problems on the ability to work and carry out daily activities.
Change in questionnaire based on the Medical Consumption Questionnaire (iMCQ) baseline, follow-up (15 weeks after baseline) The iMCQ measures healthcare consumption.
Trial Locations
- Locations (2)
Ghent University
🇧🇪Ghent, Oost-Vlaanderen, Belgium
Ghent University Hospital
🇧🇪Ghent, Oost-Vlaanderen, Belgium